A Second Zohydro Update

Last week I posted about Judge Rya Zobel’s order enjoining the Massachusetts Zohydro ban. While writing that post, I was wondering how Massachusetts would respond to the injunction. Now we know the answer. The night before the injunction was to go into effect, Governor Deval Patrick announced that the state would not appeal Judge Zobel’s order, and, instead of an outright ban on the use of Zohydro, Massachusetts would impose certain restrictions on its use similar to what Vermont has done.

The restrictions that Massachusetts has imposed include requiring Zohydro prescribers to complete a risk assessment and pain management agreement with patients, and participate in Massachusetts’s Prescription Drug Monitoring Program, which collects dispensing information on controlled substances to detect misuse. If Zogenix chooses to challenge these restrictions – and I’m guessing it won’t because it hasn’t yet sued Vermont over its similar restrictions – one legal question would be: Are these restrictions, like the outright ban, preempted by federal law?

I think the answer to that question is likely “no.” At least, I don’t think these restrictions would be preempted for the same reasons that Judge Zobel concluded that the ban on Zohydro was preempted. In reaching her conclusion about the ban, Judge Zobel considered both that Massachusetts made an independent assessment of Zohydro’s safety and effectiveness that replaced FDA’s assessment, and that Zogenix could not market Zohydro in Massachusetts without going back to FDA for approval of an entirely new drug product. The new Massachusetts restrictions do not present the same challenges to the federal regulatory scheme because they do not so directly replace a federal action, and Zogenix can now market Zohydro in Massachusetts without any additional interaction with FDA.

That is not to say there are no colorable preemption arguments. For example, Zogenix might try to make an implied preemption argument that relies on the fact that federal law also restricts Zohydro’s use. Prescribers and dispensers of Zohydro must comply with the requirements of the Controlled Substances Act, including registering with the Drug Enforcement Administration. Additionally, Zohydro, like other long-acting/extended-release opioids, is subject to an FDA-required risk evaluation and mitigation strategy (REMS), which, among other things, requires Zogenix to provide training to prescribers. Particularly because under its REMS authority FDA could have required Zogenix to put in place at least some measures for Zohydro akin to what Massachusetts has required, Zogenix might argue that FDA made a determination that such restrictions are not needed for the safe and effective use of Zohydro, and Massachusetts’s restrictions are inconsistent with that determination.

I don’t think this argument would likely be successful because, without an outright ban on the use of an approved drug, the restrictions that Massachusetts has put in place look a whole lot more like regulating the practice of medicine – an area traditionally subject to state regulation — than replacing FDA’s role as the gatekeeper for medical products in the United States. But I might be wrong (just as I was wrong in predicting that Judge Zobel would not enjoin the ban on preemption grounds). And it will be interesting to see if FDA’s REMS authority (at 21 U.S.C. § 355-1) – which was added to the Federal Food, Drug, and Cosmetic Act in 2007 and thus is relatively new – gives rise to any novel preemption arguments in this context or others.